RP-HPLC法测定比沙可啶片剂含量及有关物质  

Determination of Content of Bisacodyl Tablet and Its Related Substances by RP-HPLC

作　　者：王卉[1] 杜春波[1] 沈立[1] 刘文英[2] 

机构地区：[1]中国药科大学制药有限公司质量部,江苏南京210009 [2]中国药科大学药物分析教研室,江苏南京210009

出　　处：《药学进展》2005年第12期565-568,共4页Progress in Pharmaceutical Sciences

摘　　要：目的建立RP-HPLC法测定比沙可啶片剂含量及有关物质。方法色谱柱为Hypersil ODS C18(300mm×4mm,5μm),以乙腈-水(45∶55)为流动相,流速为1.0mL/min,进样量为10μL,检测波长为265nm。结果比沙可啶浓度在0.115～1.150g/L范围内,色谱峰面积与浓度线性关系良好,r=0.9999;线性范围内3个浓度的平均回收率(n=3)分别为99.2%(RSD=0.68%)、99.3%(RSD=0.21%)和99.1%(RSD=0.87%)。样品中有关物质检查符合质量要求。结论该方法简便、快速、准确、重现性好,可用于比沙可啶片剂的含量测定和有关物质检查。Objective：To establish a RP-HPLC method for the determination of content of bisacodyl tablet and its related substances. Methods： A Hypersil ODS Cis column and acetonitrile-water（45：55） as the mobile phase were used at the flow rate of 1.0 mL/min and the injection volume of 10μL. The detection wavelength was 265 nm. Results： The calibration curve was linear in the range of 0. 115- 1.150 g/L, r = 0.9999. The average recoveries from 3 concentrations（ n = 3 ） were 99.2 % （ RSD = 0.68 % ）, 99.3 % （ RSD = 0.21% ） and 99.1% （RSD = 0.87 % ） respectively. The examining result of related substances in sample conformed to quality requirement. Conclusion：This method is simple, rapid, accurate and reproducible. It can be used for the determination of content of bisacodyl tablet and its related substances.

关 键 词：反相高效液相色谱法 比沙可啶片剂 含量测定 有关物质 

分 类 号：TQ463.53[化学工程—制药化工]